Updated: June 14, 2020 7:22:27 am
The list of symptoms has been revised in the new protocol to include the loss of smell and taste.
Off-label use refers to the prescription of a drug for a condition other than what it has been officially approved for.
Remdesivir is an antiviral that was originally developed in 2014 by the California based biopharma company Gilead Sciences for the treatment of Ebola.
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It is being repurposed for treatment of Covid-19, and was cleared by the Drugs Controller General of India, India’s top drug regulatory body, on June 1 for the treatment of suspected or laboratory-confirmed cases of Covid-19 in adults and children hospitalised “with severe disease”.
The drug, which is one of the most keenly watched in the search for a cure for the novel coronavirus disease, is part of the Word Health Organisation’s ongoing Solidarity Trials, and it received emergency use authorisation by the United States Food and Drug Administration (USFDA) on May 1.
Tocilizumab is an immunosuppressant that is commonly used as treatment for rheumatoid arthritis. It is manufactured by Roche Pharma and marketed by Cipla; in India, the drug is sold under the brand name Actemra. Tocilizumab has already been tried on some seriously ill patients in Mumbai.
Convalescent plasma therapy or CPT involves the transfusion of the blood plasma of a recovered patient into another patient. The procedure has been used for several diseases earlier, but its efficacy for Covid-19 is still under investigation.
The protocol has reiterated that RT-PCR – reverse transcription polymerase chain reaction – test is the only acceptable diagnostic test for Covid-19, and emphasised the importance of oxygen therapy in its treatment.
The median incubation period of the virus is 5.1 days, it says, with a range of 2-14 days. “The precise interval during which an individual with Covid-19 is infectious is uncertain. As per the current evidence, the period of infectivity starts two days prior to onset of symptoms and lasts up to eight days. The extent and role played by pre-clinical/ asymptomatic infections in transmission still remain under investigation,” the protocol says.
On remdesivir, tocilizumab, and CPT, which appear in the section on investigational therapies, the document says: “Remdesivir (under Emergency Use Authorization) may be considered in patients with moderate disease (those on oxygen)… Tocilizumab (Off Label) may be considered in patients with moderate disease with progressively increasing oxygen requirements and in mechanically ventilated patients not improving despite use of steroids. Long term safety data in Covid-19 remains largely unknown… Convalescent plasma (Off Label) may be considered in patients with moderate disease who are not improving (oxygen requirement is progressively increasing) despite use of steroids.”
Contraindications have been laid down for each of these conditions. Remdesivir, for example, is not to be used in cases of severe renal impairment, in children below the age of 12 years, and in pregnant or lactating mothers. Tocilizumab should be used only after existing infections have been checked for, and tuberculosis has been ruled out.
On HCQ, the document says: “This drug has demonstrated in vitro activity against SARS-CoV-2 and was shown to be clinically beneficial in several small single centre studies though with significant limitations. Nonetheless, several large observational studies with severe methodologic limitations have shown no effect on mortality or other clinically meaningful outcomes. As such, the evidence base behind its use remains limited as with other drugs and should only be used after shared decision making with the patients while awaiting the results of ongoing studies. As is the case with other antivirals, this drug should be used as early in the disease course as possible to achieve any meaningful effects and should be avoided in patients with severe disease. An ECG should ideally be done before prescribing the drug to measure QT interval”.
QTc is a measure related to heart rates on an electrocardiogram, and refers essentially to irregular heartbeats.
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